Submit Your IRB Proposal

The Towson University Institutional Review Board (IRB) follows a monthly deadline system for application submissions and reviews. Read further on for how the process works. 

IRB Guidance in Response to COVID-19

PLANS FOR RESTARTING HUMAN SUBJECTS RESEARCH

To minimize risk to human subjects, all research should be conducted remotely whenever possible. However, for those instances when remote research is not possible, the below guidelines should assist with the preparation and review of applications for research involving human subjects during periods when COVID-19 restrictions are in place.

Brief Overview:

  • PIs must first obtain approval to Conduct in-Person Human Subjects Research from their Department Chair, College Dean, and the Provost using the Return to Research Planning Form (RTRF).
  • PIs must submit a new IRB application or amend an existing application prior to conducting in-person research.
  • PIs must outline a remote consent process to be used until COVID restrictions are lifted. The consent process will include a University-developed document (COVID-19 Risks Statement) that outlines risks specific to participating in research when COVID-19 restrictions are in place.
  • PIs must require participants to complete and return the Screening Questionnaire to the PI on the day prior to their scheduled appointment on campus, and repeated in person as the first activity of their on-campus visit. This form must be included with your amendment or new application materials and be approved by the IRB before screening can commence.

For complete detail and step-by-step instructions, follow the guidance posted below:

  1. HSR Guidelines (DOCX)/(PDF)
  2. HSR Procedures (DOCX)/(PDF)
  3. Return to Research Planning Form (RTRF) (DOCX)/(PDF)
  4. Screening Questionnaire (DOCX)/(PDF)
  5. COVID-19 Risks Statement (to be included in the consent process) (DOCX)/(PDF)

You may also visit the Provost’s website or Return to TU Guidance & Protocols webpage for information on the Return to Research phases.

 

Moving Studies to an Online Process

The IRB has issued the following Guidance for IRB Approved Studies (DOCX) that need to move online for data collection.

The IRB continues to strive to respond to protocols in a timely manner, however, delays may occur given the unique situation. Ultimately, protocol approvals rely on the completeness of the application, timeliness of the PI returning any revisions, and reviewer approval. We sincerely appreciate your understanding and look forward to working with you for the Fall 2020 semester.

Next Deadline: October 16

Standard review submissions will follow the deadline and review process as outlined below. All materials must be received no later than the next deadline date.

*Accelerated and amended applications continue to be accepted on a rolling basis.

Review Timelines

Please allow time for administrative processing. You should expect a response within 2 weeks (10 business days) for accelerated review or 15 business days for standard review within receipt of your confirmation email that it has been submitted to a reviewer. 

A note to help get you started

The PI Manual 

A Principal investigator (PI) manual (PDF/DOCX) has been developed to help researchers navigate the IRB process and complete their application. The IRB strongly suggests that all researchers refer to this manual when preparing their proposals. Click on a topic within the Table of Contents to go directly to the section you wish to read. 

Template Consent Form

The IRB has created a template consent form (PDF/DOCX) with required/optional sections, as well as recommended language that all TU investigators should adhere to. The IRB will heavily reference this template in their reviews. Please follow carefully to avoid minimum revisions after submission. 

Navigating Kuali Protocols

Not sure how to submit in the new system? View our Kuali Protocols User Guide PowerPoint.

In addition, you can visit the Kuali Protocols Support Page for step-by-step instructions on each phase of the submission and review process, including amending, renewing, and closing out protocols. 


Steps to Submission, Review and Approval

The IRB reviews all proposals for human subjects' research before the research is conducted to ensure that the research plan adequately protects human subjects.  

  1. Determine if your research requires IRB review. Not all research requires review and approval from the IRB. Your research must meet the definition of Human Subjects Research. Visit the PI (principal investigator) manual for more information on this.
  2. Determine the next deadline date you must submit all materials by. (*See below for the most up-to-date information.)
  3. If you are a student investigator: find a faculty advisor who will oversee and help guide you through your research. You must have a faculty advisor in order for your study to be reviewed and approved. Your advisor will need to complete the Faculty Advisor Agreement (DOCX/PDF). This will need to be attached separately in your online protocol for it to be accepted and reviewed by the IRB. 

  4. Complete CITI Human Subjects Training. Please note that all investigators who are directly involved with human subjects and data collection/analysis must complete training. Please be mindful of who is considered a co-investigator and is directly involved with human subjects and data collection/analysis.

    Kuali Protocols will automatically pull CITI certificates into your online protocol when you add TU faculty, staff, or students. External investigators will need to have their certificates attached separately.

    Applications will not move forward to review until certificates of completion have been received from ALL study personnel. 

  5. Determine if your research falls under accelerated, standard, or full board review. You will need to know which kind of review your research will fall under in order to submit for the appropriate review timeline. 

    Kuali Protocols has a general questionnaire that will populate the correct application for your type of review. 

  6. Complete your application, attach all supporting documents, necessary signatures, and submit electronically in Kuali Protocols. 

Deadlines

Each month has a deadline for when applications requesting standard or full board review must be submitted by in order to be reviewed and approved within a 2-3 week time-frame of the deadline date. This is to guarantee that you will hear back on the status of your application by a certain date (usually by the 2nd or 3rd Friday of the following month).

Completed applications are typically due by 11:59 p.m. on the 3rd Friday of the month. Applications received after this date WILL NOT be sent for review until the next deadline. 

NOTE: IRB meeting dates may be canceled if no requests for Full Board review are received. 

2020 IRB SCHEDULE AND DEADLINES

Thanksgiving Break

The University will be CLOSED for the Thanksgiving holiday from November 25 – November 29. Please note that reviews will not be taking place during this time. 

Winter Break

The University will be CLOSED for Winter Break from December 24 - January 1. You may submit applications throughout the break; however, new applications will not be processed and no reviews will take place during this time. There will also be a delay in receiving review comments due to the closure. You can expect to receive comments in mid-January.

Application Deadlines IRB Meeting Dates
August 21 September 18
September 18 October 16
October 16 November 20
November 20 December 18
December 18 TBD


Note to early applicants

TU adheres to a strict deadline in order to promote fairness in review length timelines. Should you submit your application in advance of the next deadline, please note that your application will be processed, but will not be submitted for review to an IRB reviewer until that deadline date.